Portable Neuromodulation Stimulator Registry for People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology
研究概览
简要总结
The Registry will be designed to gather information over 3 years. This important health economic information will help to establish the value of the PoNS Device on key therapeutic outcomes. These outcomes will include:
disease-associated injury risks (i.e., falls), onset of new comorbidities and/or worsening/improvement of existing medical condition(s) (other than gait deficit/impairment), need for new pharmacological/non-pharmacological intervention or increase/decrease of ongoing pharmacotherapy or other non-pharmacological intervention, increase/decrease of in patient/outpatient hospital and/or office visits or stays, side effects.
By participation in the Registry, patients and physicians will be providing Helius with access to information about medical history, medical diagnoses, clinical symptom presentations, vocational information, medications, pharmacologic and non-pharmacologic prescriptions, hospitalization and healthcare visits, and any reported therapy's adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of gait deficit due to MS
排除标准
- •unable to ambulate with or without an assisting device
结局指标
主要结局
Effectiveness of PoNS Therapy as measured by self-reported change in symptomatology
时间窗: 3 years
Balance and Gait deficit improvement after physical therapy rehabilitation with PoNS device over one or more courses of 14-week therapy
次要结局
未报告次要终点
